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Pirfenidone

Pirfenidone is an oral prescription medicine (sold as Esbriet and as generic pirfenidone capsules and tablets) used to treat idiopathic pulmonary fibrosis (IPF), a lung scarring disease.

Brand name Esbriet
Drug class Pyridone
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 35 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 4, 2026
Pirfenidone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Pirfenidone (Esbriet), on the U.S. market for over a decade and available as a generic, is one of the two main specialist medicines that slow idiopathic pulmonary fibrosis (IPF), lung scarring with no known cause, though how it works is not established. It is often hard going early on, mainly nausea, poor appetite and indigestion in the first three months, plus a sunburn-like rash after sun exposure. Watch most closely for liver injury, and report dark urine, yellowing skin or eyes, or upper right belly pain promptly. Liver blood tests come before you start, monthly for six months, then every three months.

Clinical pearls

  • Take each dose with food, ideally a meal, since an empty stomach makes the nausea noticeably worse.
  • Wear sunscreen and protective clothing every day and avoid sunlamps, since the rash is triggered by sun exposure.
  • Smoking lowers pirfenidone levels and may weaken its effect, so quitting before and during treatment protects the medicine itself.
  • Make sure every prescriber knows you take it, especially before starting fluvoxamine or ciprofloxacin, which raise pirfenidone levels.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record2000
Companies listing it with the FDA23
FDA label last updatedDec 5, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Pirfenidone, written from its FDA label.

What Pirfenidone is used for

▾

Pirfenidone is used for one condition across its supported products.

  • Idiopathic pulmonary fibrosis (IPF): Esbriet, pirfenidone capsules and pirfenidone tablets are each indicated for it.

How Pirfenidone works

▾

How pirfenidone helps in IPF is not known. Its mechanism of action has not been established.

Pirfenidone dosage

▾

Pirfenidone is taken by mouth three times a day with food, at about the same times daily. Treatment begins with a lower amount and steps up to the full amount over 14 days.

  • Don’t take two doses at once to make up for a missed dose.
  • Don’t take more than 3 doses in a day.
  • Your doctor may lower, pause or stop treatment if side effects occur.

Follow your prescriber’s directions and the label.

Dosing details from the FDA-approved label

From the Pirfenidone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Idiopathic pulmonary fibrosis (IPF) - recommended maintenance dosage
    • 801 mg three times daily (2403 mg/day), taken with food at the same time each day
    • Maximum: Dosages above 2403 mg/day are not recommended for any patient; not more than 3 doses per day
    • Take with food; do not take 2 doses at the same time to make up for a missed dose
  • IPF - initial titration, Days 1 through 7
    • 267 mg three times daily (801 mg/day)
    • Titrate to full dosage over a 14-day period
  • IPF - initial titration, Days 8 through 14
    • 534 mg three times daily (1602 mg/day)
    • Titrate to full dosage over a 14-day period
  • IPF - Days 15 onward
    • 801 mg three times daily (2403 mg/day)
    • Maximum: 2403 mg/day
  • Patients taking strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin)
    • Reduce to 267 mg three times a day (801 mg/day)
    • Drug interaction adjustment
  • Patients taking moderate CYP1A2 inhibitors (e.g., ciprofloxacin 750 mg twice daily)
    • Reduce to 534 mg three times a day (1602 mg/day)
    • Drug interaction adjustment
  • Treatment interruption
    • If interrupted less than 14 days, the dosage prior to the interruption can be resumed
    • If 14 or more days missed, re-initiate the initial 2-week titration regimen up to the full maintenance dosage
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Take with food. Recommended dosage: 801 mg three times daily (2,403 mg/day). ( 2 ) Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Consider temporary dosage reduction, treatment interruption, or discontinuation for management of adverse reactions. ( 2.3 , 5.1 , 5.2 , 5.3 , 5.4 ) Prior to treatment, conduct liver function tests. ( 2.1 ) 2.1 Testing Prior to Pirfenidone Capsules Administration Conduct liver function tests prior to initiating treatment with pirfenidone capsules [see Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended daily maintenance dosage of pirfenidone capsule is 801 mg three times daily for a total of 2,403 mg/day. Doses should be taken with food at the same time each day. Upon initiation of treatment, titrate to the full dosage of 2,403 mg/day over a 14-day period as follows: Table 1: Dosage Titration for Pirfenidone Capsules in Patients with IPF Treatment days Dosage Days 1 through 7 267 mg three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1,602 mg/day) Days 15 onward 801 mg three times daily (2,403 mg/day) Dosages above 2,403 mg/day are not recommended for any patient. Patients should not take 2 doses at the same time to make up for a missed dose. Patients should not take more than 3 doses per day. 2.3 Dosage Modifications due to Adverse Reactions Patients who miss 14 or more days of pirfenidone capsules should re-initiate treatment by undergoing the initial 2-week titration regimen up to the full maintenance dosage [see Dosage and Administration (2.2) ] . For treatment interruption of less than 14 days, the dosage prior to the interruption can be resumed. If patients experience significant adverse reactions (i.e. gastrointestinal, photosensitivity reaction or rash, severe cutaneous adverse reactions (SCAR)), consider temporary dosage reductions or interruptions of pirfenidone capsules to allow for resolution of symptoms. If a SCAR is confirmed, permanently discontinue pirfenidone capsules [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Pirfenidone side effects

▾

Many people have some side effects, most often stomach or skin related.

Common side effects

  • Nausea
  • Rash
  • Stomach pain
  • Diarrhea
  • Tiredness (fatigue)
  • Headache
  • Decreased appetite
  • Indigestion (dyspepsia)
  • Upper respiratory tract infection
  • Indigestion, dizziness, vomiting, acid reflux, sinusitis, trouble sleeping, weight loss and joint pain

When to get medical help

  • Call your doctor if you have unusual tiredness, loss of appetite, pain in the upper right belly, dark urine, or yellowing of the skin or eyes. These can be signs of liver injury.
  • Get medical help right away for a severe skin reaction, such as widespread rash, blistering or peeling skin, or rash with fever and body-wide symptoms (SJS, TEN or DRESS). Pirfenidone must be stopped if one is confirmed.
  • Tell your doctor about a sunburn-like rash or skin reaction after sun exposure.
  • Tell your doctor if nausea, vomiting, diarrhea or stomach pain is bad or doesn’t ease, since your dose may need adjusting.

Pirfenidone warnings and precautions

▾
  • Liver injury: Enzyme elevations and drug-induced liver injury have occurred, including rare fatal cases. Liver tests are done before treatment, monthly for 6 months, then every 3 months.
  • Sun sensitivity and rash: Photosensitivity was reported in 9% of people taking pirfenidone vs 1% on placebo. Avoid sun and sunlamps, use sunscreen and cover up.
  • Severe skin reactions: SJS, TEN and DRESS have been reported. Pirfenidone is interrupted for signs of these and stopped permanently if confirmed.
  • Stomach problems: Most common in the first 3 months and often ease over time.

Pirfenidone interactions

▾

Pirfenidone is broken down mainly by an enzyme called CYP1A2, so drugs that affect it matter.

  • Fluvoxamine and other strong CYP1A2 inhibitors: raise pirfenidone levels significantly, so are generally avoided.
  • Ciprofloxacin: raises levels moderately, so a dose reduction or close monitoring may be needed.
  • Strong CYP1A2 inducers: may lower levels and reduce effectiveness.
  • Medicines that cause sun sensitivity: add to the photosensitivity risk.
  • Smoking: lowers pirfenidone levels.

Interactions listed in the FDA-approved label

From the Pirfenidone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin): Significantly increase exposure to pirfenidone and may alter its adverse reaction profile. Concomitant use not recommended; discontinue prior to pirfenidone and avoid during treatment. If they are the only drug of choice, reduce to 267 mg three times a day, monitor for adverse reactions and consider discontinuing pirfenidone as needed.
  • Moderate CYP1A2 inhibitors (e.g., ciprofloxacin): Ciprofloxacin moderately increases exposure to pirfenidone and may alter its adverse reaction profile. If ciprofloxacin 750 mg twice daily cannot be avoided, reduce dosage; monitor patients closely when ciprofloxacin is used at 250 mg or 500 mg once daily.
  • Agents or combinations that inhibit both CYP1A2 and one or more other CYP isoenzymes (CYP2C9, 2C19, 2D6, 2E1): Moderate or strong inhibition of both CYP1A2 and other CYPs involved in pirfenidone metabolism. Discontinue prior to and avoid during pirfenidone treatment.
  • CYP1A2 inducers (strong): May decrease pirfenidone exposure and may lead to loss of efficacy. Discontinue strong CYP1A2 inducers prior to pirfenidone treatment and avoid concomitant use.
Read the label’s full interactions text

7 DRUG INTERACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Liver Enzyme Elevations and Drug-Induced Liver Injury [see Warnings and Precautions (5.1) ] Photosensitivity Reaction or Rash [see Warnings and Precautions (5.2) ] Gastrointestinal Disorders [see Warnings and Precautions (5.3) ] Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of pirfenidone. Discontinue fluvoxamine prior to administration of pirfenidone or reduce to 267 mg three times a day. Consider dosage reduction with use of ciprofloxacin. (7.1) 7.1 CYP1A2 Inhibitors Pirfenidone is metabolized primarily (70% to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Strong CYP1A2 Inhibitors The concomitant administration of pirfenidone and fluvoxamine or other strong CYP1A2 inhibitors (e.g., enoxacin) is not recommended because it significantly increases exposure to pirfenidone [see Clinical Pharmacology (12.3) ]. Use of fluvoxamine or other strong CYP1A2 inhibitors should be discontinued prior to administration of pirfenidone and avoided during pirfenidone treatment. In the event that fluvoxamine or other strong CYP1A2 inhibitors are the only drug of choice, dosage reductions are recommended. Monitor for adverse reactions and consider discontinuation of pirfenidone as needed [ see Dosage and Administration (2.4) ] . Moderate CYP1A2 Inhibitors Concomitant administration of pirfenidone and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to pirfenidone [see Clinical Pharmacology (12.3) ] . If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended [see Dosage and Administration (2.4) ]. Monitor patients closely when ciprofloxacin is used at a dosage of 250 mg or 500 mg once daily.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿115 supplements and herbs with documented Pirfenidone interactions, ranked by severity Check Pirfenidone against a supplement or herb →

Before taking Pirfenidone

▾
  • The label lists no contraindications.
  • Use caution with mild to moderate liver impairment; not recommended in severe liver impairment.
  • Use caution with kidney impairment; not recommended in end-stage kidney disease on dialysis.
  • Pregnancy: human data are insufficient to know the risk.
  • Breastfeeding: no human data; weigh benefits against possible risks.
  • Children: safety and effectiveness have not been established.
  • Older adults: no dose change is needed for age.
  • Smokers should stop smoking before and during treatment.

Pirfenidone overdose

▾

There is limited experience with overdose. Healthy volunteers took higher amounts than recommended during a short study. If you suspect an overdose, get medical care, which would include supportive treatment and monitoring of vital signs.

What Pirfenidone does in the body

▾

In a study of 160 healthy volunteers, pirfenidone caused only small changes in the heart’s QT interval (a measure of the heart’s electrical timing). No one had a clearly concerning reading. The study had limits, so a firm conclusion could not be drawn.

How your body processes Pirfenidone

▾

Pirfenidone is absorbed quickly, with peak levels around 30 minutes when taken without food. Food slows absorption and lowers peak levels, and fewer side effects were seen when taken with food. The liver breaks it down, mostly using CYP1A2, and about 80% leaves in the urine as an inactive-form metabolite. Its half-life is about 3 hours in healthy people.

How to store Pirfenidone

▾

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

115

Supplements & herbs that interact with Pirfenidone

115 supplements and herbal products have documented interactions with Pirfenidone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 80
  • Minor · 34
ACTIVATED CHARCOAL Major ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALFALFA Moderate ANGELICA ARCHANGELICA Moderate ARRACH Moderate ASHITABA Moderate BACOPA Moderate +107 more
Every supplement checked against Pirfenidone — ranked by severity The full interaction hub: 1 major · 80 moderate · 34 minor · every one linked to its full report. Check Pirfenidone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Pirfenidone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Pirfenidone — the kind of thing our pharmacy team would talk through with you at the counter.

What is pirfenidone for?

▾
It treats idiopathic pulmonary fibrosis, or IPF, a lung disease where scarring builds up for no known reason. Esbriet and generic pirfenidone capsules and tablets are all labeled for it.

How should I take it?

▾
Take it by mouth three times a day with food, at about the same times each day. You’ll start low and build up over about 14 days. If you miss a dose, don’t double up, and never take more than 3 doses a day.

What side effects should I expect?

▾
Nausea, rash, stomach pain, diarrhea, tiredness and decreased appetite are common. Stomach effects are usually worst in the first few months and often ease. Tell us if they get bothersome, since your dose can be adjusted.

Do I need to do anything about the sun?

▾
Yes. Pirfenidone can make your skin sensitive to sunlight. Avoid sun and sunlamps, wear sunscreen and cover up daily. Let your doctor know if you develop a rash.

Why do I need blood tests?

▾
Pirfenidone can raise liver enzymes and, rarely, cause serious liver injury. Liver tests are done before you start, monthly for 6 months, then every 3 months. Call your doctor if you notice dark urine, yellow skin or eyes, unusual tiredness or upper right belly pain.

Do other medicines or smoking matter?

▾
Yes. Fluvoxamine and ciprofloxacin can raise pirfenidone levels, and smoking can lower them and may make it work less well. Tell me about all your medicines, and talk to your doctor about quitting smoking.

Is Pirfenidone available over the counter?

▾
No. Pirfenidone is a prescription medicine: every Pirfenidone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Pirfenidone first available?

▾
The earliest FDA record we hold for Pirfenidone is from 2000: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Pirfenidone was first used.

Who makes Pirfenidone?

▾
23 companies currently list Pirfenidone products in the FDA's NDC Directory, including Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack, Laurus Labs Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Pirfenidone on HelloPharmacist

📊Pirfenidone supplement interactions115 checked — ranked by severity 🌿Drug & Supplement CheckerPirfenidone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Pirfenidone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Pirfenidone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Pirfenidone forms and strengths (how it comes)

Pirfenidone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Esbriet
How this form is used
What it may be used for
  • Pirfenidone tablets are used to treat idiopathic pulmonary fibrosis (IPF).
  • Esbriet is labeled to treat IPF.
Important instructions
  • Pirfenidone tablets are taken by mouth with food.
  • Pirfenidone tablets are started at a lower amount and built up to full dosing over 14 days.
  • Pirfenidone tablets should not be doubled up for a missed dose.
Available strengths 3 strengths
267 mg 534 mg 801 mg
97 FDA-listed product records ⓘ

Capsule

By mouth
Brands Esbriet
How this form is used
What it may be used for
  • Pirfenidone capsules are used to treat idiopathic pulmonary fibrosis (IPF).
  • Esbriet is labeled to treat IPF.
Important instructions
  • Pirfenidone capsules are taken by mouth with food.
  • Pirfenidone capsules are started at a lower amount and built up to full dosing over 14 days.
  • Pirfenidone capsules should not be doubled up for a missed dose.
Available strengths 1 strength
267 mg
19 FDA-listed product records ⓘ

Pirfenidone on the U.S. market: products, makers and brands

How Pirfenidone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

23 companies list 60 Pirfenidone product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 2000. Brand names on the directory include Esbriet; the rest are generics.

2
Dose forms ⓘ
23
Labelers (makers, repackagers, distributors)
2
Brand names
60
FDA-listed product records ⓘ
2000
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals NY LLC10%
Bryant Ranch Prepack7%
Laurus Labs Limited7%
Aurobindo Pharma Limited5%
AvKARE5%
Cipla USA Inc.5%
Other makers62%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Pirfenidone is used (Medicaid data)

A general measure of how commonly Pirfenidone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pirfenidone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

340
Medicaid prescriptions filled (Q1–Q4 2025)
$415,273 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pirfenidone prescribed? Of the 1,601 medications we measure, Pirfenidone ranks #1,406 by Medicaid prescriptions — more than 12% of them.

Where Pirfenidone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,406 of 1,601
#1,401 Potassium Iodide 355 Rx #1,402 Flucytosine 355 Rx #1,403 Ivosidenib 351 Rx #1,404 Vonoprazan and Amoxici... 349 Rx #1,405 Pentamidine Oral Inhal... 341 Rx #1,406 Pirfenidone 340 Rx #1,407 Opicapone 337 Rx #1,408 Flavoxate 337 Rx #1,409 Ganciclovir Injection 337 Rx #1,410 Axatilimab-Csfr 333 Rx #1,411 Besifloxacin Ophthalmi... 330 Rx

Utilization by Pirfenidone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 801 mg oral tablet is the most-dispensed Pirfenidone product — about 52% of these Medicaid prescriptions.

pirfenidone 801 MG Oral Tablet Most dispensed

176 Medicaid prescriptions (Q1–Q4 2025) 52% of Pirfenidone prescriptions shown $351,857 gross reimbursement (before rebates) ≈ $1,999 per prescription (gross)

Summed across the 4 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1868018

pirfenidone 267 MG Oral Tablet

96 Medicaid prescriptions (Q1–Q4 2025) 28% of Pirfenidone prescriptions shown $33,287 gross reimbursement (before rebates) ≈ $347 per prescription (gross)

Summed across the 3 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1868014

pirfenidone 267 MG Oral Capsule

68 Medicaid prescriptions (Q1–Q4 2025) 20% of Pirfenidone prescriptions shown $30,129 gross reimbursement (before rebates) ≈ $443 per prescription (gross)

Summed across the 1 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1592279

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pirfenidone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 8 of 111 listed Pirfenidone NDCs with Medicaid activity.

Compare Pirfenidone products

A representative set of FDA-listed product records for Pirfenidone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 60 of 60 products — FDA National Drug Code Directory. See every product, package size and price: browse all 60 Pirfenidone NDCs →

Pirfenidone FDA approval history

How Pirfenidone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Pirfenidone was first approved by the FDA in 2000; the first generic version was approved in 2022. It remains available in U.S. pharmacies today.

2000
First FDA approval
2022
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Pirfenidone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Pirfenidone recall since July 2021, covering 2 product listings. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Feb 7, 2023 · Terminated · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
  • Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. ND… Lots: Batches: P2202519, P2202513 Exp. Date 4/30/2024 FDA record D-0420-2023 →
  • Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213,… Lots: Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024 FDA record D-0419-2023 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pirfenidone RxCUI 1592254 2 dose forms · 4 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1592278 In current FDA listings
    Clinical drug / strength (SCD) 267 MG RxCUI 1592279
  2. Dose form (SCDF) Oral Tablet RxCUI 1868013 In current FDA listings
    Clinical drug / strength (SCD) 267 MG RxCUI 1868014 534 MG RxCUI 2606490 801 MG RxCUI 1868018

Look up RxCUI 1592254 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Pirfenidone brand names

Pirfenidone is sold under one brand name in the FDA directory — Esbriet. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Esbriet

Who makes Pirfenidone: manufacturers and labelers

23 companies list Pirfenidone products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack, Laurus Labs Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Amneal Pharmaceuticals NY LLC 6 Bryant Ranch Prepack 4 Laurus Labs Limited 4 Aurobindo Pharma Limited 3 AvKARE 3 Cipla USA Inc. 3 Exelan Pharmaceuticals Inc. 3 Sandoz Inc 3 ScieGen Pharmaceuticals, Inc. 3 ANI Pharmaceuticals, Inc. 2 Accord Healthcare Inc. 2 Alembic Pharmaceuticals Inc. 2 Alembic Pharmaceuticals Limited 2 Apotex Corp. 2 Camber Pharmaceuticals, Inc. 2 Genentech, Inc. 2 Golden State Medical Supply, Inc. 2 Legacy Pharma USA Inc. 2 Major Pharmaceuticals 2 Micro Labs Limited 2 Northstar Rx LLC 2 Novadoz Pharmaceuticals LLC 2 Teva Pharmaceuticals, Inc. 2

Pirfenidone drug class (RxNorm)

Pirfenidone belongs to the Pyridone class.

Pharmacologic class Pyridone
Drug family (ATC) Other immunosuppressants

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Pirfenidone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 5, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pirfenidone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pirfenidone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
35
Finished products in the current FDA directory
60
Companies listing them (makers, repackagers, distributors)
23
FDA labeler codes behind them ⓘ
25
Linked representative label ⓘ
Genentech, Inc.
Linked label effective
Dec 5, 2025
Composite sections available
22
Linked SPL Set ID
2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e
Linked SPL Document ID
86848f3d-1ab2-457b-9f36-eba22bea36dd
Open the linked representative label on DailyMed ↗

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HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →